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510(k) Data Aggregation
(141 days)
PROBE HOLDER SYSTEM
The Probe Holder System is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
The Intuitive Surgical Probe Holder System is used to mount, position and hold in position uterine manipulators used in laparoscopic surgical procedures. The Probe Holder System can be mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Probe Holder System frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures. The Probe Holder System consists of two attachment mechanisms: one at its distal terminus for mounting the system to the operating room table and the other at the proximal terminus for securely grasping a surgical device. The mechanism at the distal terminus consists of jointed links, a crossbar and rail clamps while that at the proximal end is a simple mechanism for affixing detachable sterile adaptors that securely grasp a surgical device in the desired position. A handle and foot pedal actuated-mechanism facilitates rapid and secure intra-operative re-positioning of the device by the surgeon as needed. The Probe Holder System remains external to the patient's body at all times and is covered intra-operatively by sterile draping.
The provided text describes a 510(k) summary for the Intuitive Surgical Probe Holder System, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or human-in-the-loop studies.
However, based on the document's nature for a medical device (a mechanical holder), we can infer the type of "acceptance criteria" and "performance data" that would be relevant for such a device in this context. The document explicitly states that design analysis and testing were conducted to confirm that basic functional characteristics are substantially equivalent to predicate devices and that design output meets design input requirements.
Given the information provided and interpreting the request in the context of this specific regulatory submission for a non-AI/software device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria or reported performance values. Instead, it indicates a qualitative assessment of substantial equivalence. For a device like a probe holder, typical "acceptance criteria" would relate to mechanical stability, secure holding, ease of positioning, compatibility with accessories, and durability.
| Acceptance Criteria (Inferred for a Mechanical Holder) | Reported Device Performance (as stated in submission) |
|---|---|
| Securely mounts and holds uterine manipulators | "Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited." |
| Allows for stable positioning during laparoscopic procedures | "The Probe Holder System can be mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time." |
| Facilitates intra-operative repositioning by the surgeon | "A handle and foot pedal actuated-mechanism facilitates rapid and secure intra-operative re-positioning of the device by the surgeon as needed." |
| Compatible with standard operating room tables and surgical devices | "The Probe Holder System consists of two attachment mechanisms: one at its distal terminus for mounting the system to the operating room table and the other at the proximal terminus for securely grasping a surgical device." |
| Material safety and biocompatibility (where applicable) | Not explicitly detailed, but implied by "design analysis and testing... to meet design input requirements." |
| Durability and reliability under intended use conditions | Not explicitly detailed, but implied by "design analysis and testing... to meet design input requirements." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify any sample sizes for tests or the provenance of data. The "testing" mentioned refers to internal design validation and verification, which is typical for mechanical devices seeking 510(k) clearance based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the device is a mechanical holder, not an AI or diagnostic device that requires expert-established ground truth for its performance assessment in a clinical context. The "ground truth" for a mechanical device is its functional performance according to engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the device is a mechanical holder. Adjudication methods are typically used in studies involving subjective interpretations (e.g., radiology reads) to establish consensus ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done or is relevant for this mechanical device. This type of study is specific to AI/CAD systems that assist human operators in tasks like image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a mechanical holder and does not involve an "algorithm" or standalone AI performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this mechanical device is its engineering specifications and functional requirements (e.g., holding force, range of motion, stability, compatibility). These are established through design inputs and verified through engineering tests.
8. The sample size for the training set
This section is not applicable as there is no "training set" for a mechanical device like this. Training sets are used for machine learning models.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this device.
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(141 days)
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is an accessory intended for use in conjunction with a transvaginal ultrasound transducer. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System is intended to seize and hold the cervix and to hold and secure an ultrasound transducer in place, while performing sonographic procedures.
The Safe TChoice™ Transvaginal Ultrasound Probe Holder System is an accessory used in conjunction with a transvaginal ultrasound transducer. The device is intended to hold and secure the ultrasound transducer in place on a uterine tenaculum, while performing the sonographic procedure. The configuration of the device allows the physician to manipulate the ultrasound transducer with one hand, thus freeing the other hand to perform the required procedure. The SafeTChoice™ Transvaginal Ultrasound Probe Holder System consists of a reusable uterine tenaculum with an adaptor bar, a sterile, disposable adaptor and a disposable probe connector.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the SafeTChoice™ Transvaginal Ultrasound Probe Holder System, outlining its description, indications for use, and a claim of substantial equivalence to a predicate device. It includes the FDA's clearance letter.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically found in performance studies, validation reports, or clinical trial summaries, which are not present in this 510(k) summary. The 510(k) process for this specific device relies on substantial equivalence to a legally marketed predicate device rather than new performance data against acceptance criteria.
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